Abstract
Background/Objectives: In Sudan, oral cancer is one of the top ten most common cancers, with OSCC representing the majority of the cases. To date, despite the fact that saliva can be collected simply and non-invasively, there is no approved salivary tumor marker for OSCC. This study aimed to investigate the reliability of salivary CA-125 as a tumor marker for OSCC by measuring and comparing its level among OSCC and healthy individuals as well as its level across different histopathological grades. Methods: A total of 100 subjects were enrolled; 50 were patients with OSCC, while the other 50 were matched healthy individuals. Non-stimulated whole saliva was collected before the administration of definitive treatment, and the concentration of salivary CA-125 was quantified using an automated immunoassay analyzer that employs a one-step sandwich fluorescent enzyme immunoassay (FEIA). Results: The level of salivary CA-125 was 342.65 U/mL in the cases group, which was significantly increased compared with 203.65 U/mL in the healthy controls (p = 0.017). Statistically significant differences in the level of salivary CA-125 among different histopathological grades were observed (p = 0.014). The sensitivity, specificity, accuracy, and positive and negative predictive values were 48%, 78%, 63%, 68.6%, and 60%, respectively. Conclusions: This study suggests that salivary CA-125 could serve as a potential tumor marker for OSCC. However, its clinical application requires further validation.